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AzTrials

Salivary Glands TumorsPhase 2SG-ABI14NCT02867852

Abiraterone Acetate in Patients With Relapsed and/or Metastatic Salivary Gland Cancers

A Phase 2 study testing Abiraterone acetate in people with Salivary Glands Tumors, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise specified) distinguish themselves for the expression of androgen receptors (AR), which is reported in 21% to 43% of the cases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Salivary Glands Tumors
What is being tested?
Abiraterone acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteItaly
Study dates
Mar 2015to May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age ≥18 years
  • Histologically or cytologically confirmed salivary glands cancer
  • At least, one target lesion defined as RECIST 1.1 (clear progression of disease is required in the presence of one target lesion previously treated with radiotherapy
  • Clinical and/or radiological progression of disease on ADT
  • Ongoing androgen deprivation with a serum testosterone level of less than 50 ng per deciliter (1.7 nmol per liter)
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  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Adequate bone marrow function: Neutrophils > 1.5 x 109/L; Hemoglobin ≥ 9.0 g/dL independent of transfusion and platelet count ≥ 100,000/μL
  • No limits are required for the number of previous chemotherapy lines
  • Serum albumin ≥ 3.0 g/dL
  • Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min
  • Serum potassium ≥3.5 mmol/L
  • Able to swallow the study drug whole as a tablet
  • Patients with treated brain metastases, stable within the last three months, are allowed
  • Subjects who have partners of childbearing potential must use a method of birth control with adequate barrier protection as determined to be acceptable by the investigator and for 13 weeks after last study drug administration

Who cannot join

  • Received abiraterone acetate within the last 5 years
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Abnormal liver functions consisting of any of the following:
  • Serum bilirubin ≥ 1.5 x ULN (except for subjects with documented Gilbert's disease, for whom the upper limit of serum bilirubin is 3 mg/dL)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 x ULN
  • Patients with ALT and/or AST not exceeding 5 x ULN due to liver mets can be enrolled
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  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline
  • History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
  • Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of ≤1
  • Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study entry

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

Other trials in Italy

About this study

Official title: Phase II Trial of Abiraterone Acetate in Patients With Relapsed and/or Metastatic, Castration Resistant Salivary Gland Cancers

Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise specified) distinguish themselves for the expression of androgen receptors (AR), which is reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or disseminated AR-expressing disease. No other therapy except palliative chemotherapy is available after progression on ADT, thus underling the necessity of alternative therapeutic approaches.

Read the detailed description

Carcinomas of the salivary glands (SGC) are rare tumors. They comprise less than 1% of all cancers of the head and neck. The standard treatment is surgical excision, followed by radiotherapy in selected cases, such as high-grade tumors, and/or in the presence of perineural invasion, and/or in the presence of advanced disease. Some selected salivary gland histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise specified) distinguish themselves for the expression of androgen receptors (AR), which is reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or disseminated AR-expressing disease.

The proven activity of ADT in AR expressing SGC as well as in Pca, suggests a common clinical behaviour by apparently sharing the same biological background. Once Pca becomes resistant to castration it still remains driven by ligand-dependent AR signaling and further hormonal manipulations are active and efficacious. Abiraterone acetate is currently approved by FDA for castration-resistant prostate cancer (CRPC). We treated with abiraterone two patients with AR-positive adenocarcinoma who had progressed on ADT, both patients showed a partial response suggesting the activity of a second line hormonal therapy in SGCs.

Based on the above biological and clinical evidences, the aim of the trial is to assess the activity of abiraterone in AR-expressing castration resistant SGCs.

Being tested
Abiraterone acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetateDrug

    Also called Zytiga

    Abiraterone acetate is a prodrug of abiraterone, an irreversible inhibitor of 17α hydroxylase/C17, 20-lyase (cytochrome P450c17 [CYP17]), a key enzyme required for testosterone synthesis. This enzyme is found in the testes, adrenals, prostate tumors

Study groups in NCT02867852
Study groupRoleWhat they receive
Abiraterone acetateExperimentalAbiraterone acetate 1 g/day must be taken as four 250-mg tablets daily on an empty stomach. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least 1 hour after the dose of abiraterone acetate is taken. Prednisone (prednisolone when prednisone is not available) 5 mg will be given orally twice a day.
Receives: Drug: Abiraterone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    The assessment of the activity considered as the response rate of abiraterone acetate in castration resistant salivary glands cancer

    Measured: 4 years

Secondary outcomes (4)

  1. Disease Control Rate

    The assessment of disease control rate of abiraterone acetate in castration resistant salivary glands cancer

    Measured: 4 years

  2. Adverse Events incidence

    Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0

    Measured: 4 years

  3. Progression free survival

    The assessment of progression free survival of patients suffering from castration resistant salivary glands cancer enrolled and treated wuth abiraterone acetate

    Measured: 4 years

  4. Overall survival

    The assessment of overall survival of patients suffering from castration resistant salivary glands cancer enrolled and treated wuth abiraterone acetate

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionNov 2019
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867852
Sponsor's protocol ID
INT 71/14
Acronym
SG-ABI14
Status last verified
Mar 2021
First submitted
11 Aug 2016
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Abstract presentation to National and International congresses and final data publication on indexed papers

Publications

  • Locati LD, Cavalieri S, Bergamini C, Resteghini C, Colombo E, Calareso G, Mariani L, Quattrone P, Alfieri S, Bossi P, Platini F, Capone I, Licitra L. Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial. J Clin Oncol. 2021 Dec 20;39(36):4061-4068. doi: 10.1200/JCO.21.00468. Epub 2021 Oct 1.

    PubMed 34597119

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate in people with Salivary Glands Tumors, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867852, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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